JP5303792B2 - Aseptic sucralose solution without preservatives - Google Patents

Description

The present invention relates to a novel composition of a dietary supplement and a method for producing the same. The present invention relates to a sterile solution-like sucralose which is a sweetener and does not contain a preservative.

This sweetener is mainly used by people who suffer from diabetes and weight problems. It is also widely used in other fields such as the food industry for diet and other applications.

Diabetes mellitus is caused by a disease caused by insufficient secretion of insulin by the pancreas (called insulin-dependent or type I diabetes) or insufficient tissue acceptance of insulin that causes sugar diabetes characterized by abnormally elevated blood sugar. Which is called non-insulin dependent or type II diabetes, this latter type of diabetes, also called fat diabetes, because the affected patient is generally obese, and 90% of diabetics Related to the above.

Obesity and overweight problems, in particular childhood obesity, are considered as increasingly serious health problems.

Saccharin was first discovered after 1857. However, it is only in recent years that it has become clearly conscious, and the market has seen progressive development of low-calorie or non-calorie sweetener products.

The most widely used sweeteners are saccharin, cyclamate and aspartame.

In some countries saccharin and tichro have been banned because they may have carcinogenic effects.

Aspartame is also considered non-hazardous, except for undesirable minor effects after prolonged use, such as migraines. Aspartame is also poorly stable and degrades upon heating to produce toxic products.

Therefore, sucralose was developed in 1976 to overcome these drawbacks. It is a sweetener obtained from natural sugar or sucrose, and its sweetness is 600 times that of sugar.

Its use was first approved in Canada in 1991. Subsequently, it was approved in Australia in 1993, in New Zealand in 1996, in the United States in 1998, EU in 2004 and Switzerland in 2006. Currently it is approved for use in more than 23 countries.

Sucralose exhibits several advantages compared to other sweeteners. There is no carcinogenicity, heat stability (as opposed to aspartame), solution stability over a wide pH range, and therefore longer lifetime.

Sucralose can also be used for food products before baking or for food products with a long shelf life.

In addition, sucralose has no carcinogenic action, is non-cariogenic and does not favor the growth of dental caries.

The EU allows the addition of sucralose to the following products (the list below is not exhaustive).
・ Non-alcoholic beverages ・ Deserts and similar products ・ Sugar candy ・ Mustard

Sucralose is commercially available and is primarily in the form of a powder or tablet and may be in solution with preservatives.

The solution form exhibits greater stability, however, the presence of preservatives in the solution form presents several disadvantages and the risk of undesirable effects.

  Therefore, there is a need to achieve a liquid form that is free from the effects of troublesome preservatives, is more stable, and is easier to use.

  Therefore, the present invention aims at a novel composition capable of producing sucralose in a sterile solution that does not require the addition of a preservative and a method for producing the same.

The present invention includes sucralose and water for an injectable preparation manufactured in a completely sterile condition that produces a sterile product that does not require the addition of preservatives.

All manufacturing operations are performed in accordance with the standards of the manufacturing control standard (Bonnes Pratices de Fabrication) that regulates the manufacture of aseptic products.

The metering and bulk preparation operations are carried out under a laminar flow of class C, where the bulk preparation dissolves the sucralose powder in water, produces an injectable preparation, and stirs until it is completely dissolved, with a final volume. Adjusting to produce solutions with concentrations ranging from 0.1 mg / ml to 1 g / ml depending on the choice.

The resulting solution is then properly sterilized by one of various sterilization methods for the product.

Sterilization is performed in particular by sterilization filtration using a 0.22 μm hydrophilic filter.

The resulting sterile solution is then aseptically dispensed into a plurality of bottles under a Class A laminar flow. Also, bottle closure is performed under the same conditions.

The sterile solution sucralose of the present invention is packaged in various volumes of bottles, which may also be infusion bottles.

The present invention exhibits the following advantages.
-Simple to use: Can dissolve very quickly in beverages, coffee, tea and sweets.
-Easy to use and homogenize in paste and semi-solid form.
-As an infusion bottle, it is convenient to use a sucralose bottle that is small, practical, and clean.
-The stability of this solution is greater.
-Resistance to baking heat: Sucralose is a heat-resistant molecule.
・ There is no preservative.

Claims (6)

A sucralose sterile solution composition for injection preparations, prepared by a method comprising the following steps (a) to (d); comprising a sterilized solution of sucralose and water without containing a preservative.
(A) a metering and bulk preparation operation is performed under laminar flow of Class C, the bulk preparation further comprising dissolving sucralose powder in water for injection formulation;
(B) shaking the sucralose solution until the sucralose powder is completely dissolved in water;
(C) sterilizing the solution obtained in step (b); and (d) aseptically dispensing the sterile solution obtained in step (c) into a plurality of bottles under laminar flow of class A. The composition according to claim 1, wherein the composition consists of water for injection preparations and sucralose, manufactured in a completely sterile state without the need for the addition of preservatives. The composition according to claim 1, wherein the concentration of the solution obtained in step (b) is in the range of 0.1 mg / ml to 1 g / ml. A method for producing a sterile sucralose solution composition for injection preparations, comprising a sterilized solution of sucralose and water without containing a preservative; comprising the following steps (a) to (d) And the method.
(A) a metering and bulk preparation operation is performed under laminar flow of Class C, the bulk preparation further comprising dissolving sucralose powder in water for injection formulation;
(B) shaking the sucralose solution until the sucralose powder is completely dissolved in water;
(C) sterilizing the solution obtained in step (b); and (d) aseptically dispensing the sterile solution obtained in step (c) into a plurality of bottles under laminar flow of class A. The process according to claim 4, characterized in that it comprises producing a solution in which the concentration of the solution obtained in step (b) is in the range of 0.1 mg / ml to 1 g / ml. The method according to claim 4 or 5, wherein the sterilization in the step (c) is performed by sterilization filtration using a 0.22 µm hydrophilic filter.